Music to Reduce Use of Smoking in Patients With Schizophrenia

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03190161
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Actual Duration (Months): 18.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to explore the impact of self-selected music listening which targets disrupting the reward process maintaining smoking and additionally attenuating the reward processing deficits associated with schizophrenia. Five participants with schizophrenia/schizoaffective disorder who smoke/nicotine will participate in an individual session of self-selected music listening for a half an hour.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Nicotine Dependence; Smoking, Tobacco	Behavioral: Music session	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Music to Reduce Use of Smoking in Patients With Schizophrenia
• Actual Study Start Date: Mar 9, 2017
• Actual Primary Completion Date: Sep 17, 2018
• Actual Study Completion Date: Sep 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Schizophrenia Patients Clinician verification diagnosis of Schizophrenia or Schizoaffective Disorder	Behavioral: Music session; Participants will be asked to refrain from smoking from 24 hours before the music listening session as confirmed by breath carbon monoxide level <6 ppm on the day of the session. They will be contacted by phone or in person at the clinic as a reminder prior.

Outcome Measures

Primary Outcome Measures

1. Snaith-Hamilton Pleasure Scale (SHAPS) [1 Day]

   Measures Pleasure Pre Music Session

2. Snaith-Hamilton Pleasure Scale (SHAPS) Post Music Session [1 Day]

   Measures Pleasure Post Music Session

3. Pleasure Rating Scale (PRS) [1 Day]

   Measures Pleasure Pre Music Session

4. Pleasure Rating Scale (PRS) Post Music Session [1 Day]

   Measures Pleasure Post Music Session

5. Questionnaire of Smoking Urges-Brief (QSU-B) [1 Day]

   Measures Cravings Pre Music Session

6. Questionnaire of Smoking Urges-Brief (QSU-B) Post Music Session [1 Day]

   Measures Cravings Post Music Session

7. Minnesota Nicotine Withdrawal Scale (MNWS) [1 Day]

   Measures Withdrawal Pre Music Session and Post Music Session

8. Minnesota Nicotine Withdrawal Scale (MNWS) Post Music Session [1 Day]

   Measures Withdrawal Post Music Session

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• clinician verification diagnosis of Schizophrenia or Schizoaffective Disorder

• smoked at least 10 cigarettes per day for the past month

• score of 4 or more on the Fagerstrom Test for Nicotine Dependence73

• psychiatric stability (e.g., no psychiatric hospitalizations within the last year, no expectation for medication change during study participation, no active suicidal ideation, no symptoms that interfere with ability to participate in study activities)

• the capacity to participate in the informed consent process

Exclusion Criteria:

• being medically unstable (e.g., medical condition that requires frequent medical appointments or hospitalizations and interferes with ability to participate in study activities)

• report active substance abuse or testing positive drug or alcohol use

• taking bupropion, varenicline, nicotine replacement products and/or involved in any other smoking cessation treatment

• participating in any treatment or activity that includes music as a focus

• having a seizure disorder, other neurological illnesses, or a family history of seizures

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Kathleen Tracy, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03190161
• Other Study ID Numbers: 17-00001
• First Posted: Jun 16, 2017
• Last Update Posted: Aug 15, 2019
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by NYU Langone Health: Schizophrenia
• Additional relevant MeSH terms: Tobacco Use Disorder; Schizophrenia

Study Results

No Results Posted as of Aug 15, 2019